Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00045786
First received: September 9, 2002
Last updated: June 23, 2005
Last verified: May 2004
  Purpose

The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: CC-1088
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Estimated Enrollment: 39
Study Start Date: October 2001
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
  • Patient must be able to adhere to the study visit schedule and other protocol requirements.
  • Patient must understand and voluntarily sign an informed consent document.
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
  • Women must not be pregnant or lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045786

Locations
United States, Illinois
Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, United States, 60612-3515
Sponsors and Collaborators
Celgene Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00045786     History of Changes
Other Study ID Numbers: CC-1088-MDS-801-001
Study First Received: September 9, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
myelodysplastic syndrome

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014